FDA Device Recalls

Class IOngoing

Model Number L111, ESSENTIO DR SL MRI Pacemaker

Boston Scientific Corporation

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

August 20, 2025 · DeviceView details →

Model Number L121 ESSENTIO DR EL Pacemaker

Model Number L110, ESSENTIO SR SL MRI Pacemaker

Model Number U225 VISIONIST CRT-P EL

Model Number L210 PROPONENT SR SL Pacemaker

ACCOLADE DR SL (Model L301)

ACCOLADE DR EL (Model L321)

Model Number S701 ALTRUA 2 SR SL Pacemaker

Model Number L111, ESSENTIO DR SL MRI Pacemaker

ACCOLADE SR SL (Model L300)

Model Number U125, VALITUDE CRT-P EL

Model Number L100, ESSENTIO SR SL Pacemaker

ACCOLADE SR SL MRI (Model L310)

PROPONENT DR SL (Model L201)

Model Number S722, ALTRUA 2 DR EL Pacemaker

ACCOLADE DR SL MRI (Model L311)

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B

Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B